The aim of the study is to assess current practice within PROP & lung teams, for treating asymptomatic patients with centrally located non-small cell lung cancer (NSCLC), and to observe outcomes for those patients receiving immediate or deferred RT. This is a prospective cohort trial. Patients will be managed by immediate radiotherapy (RT) or a deferred approach according to physicians' individual current clinical practice. Baseline and follow-up data collection will be structured to focus on patient-reported measures to describe clinical outcomes in the two management groups. Indications for prescribing RT and dose fractionation schedules will also be collected. A new intervention will not be introduced during this trial. Instead, a follow-up regimen will be offered to both groups of patients, so that RT can be offered to the deferred group of patients if/when symptoms develop, and we can monitor symptoms/toxicities and QoL in both groups of patients.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

To determine the pattern of practice for management (immediate radiotherapy, deferred radiotherapy) of patients with ACLA-NSCLC, including reasons, timing and dose fractionation of lung/mediastinal RT [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the patient reported outcomes (symptoms, toxicities and quality of life measures) in patients with ACLA-NSCLC at 4 and 12 months [ Time Frame: 6 years ] [ Designated as safety issue: No ]

To explore the relationship between utility and initial treatment decision (immediate versus deferred) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

To describe the disease status (as per CT imaging) at 4 months [ Time Frame: 6 years ] [ Designated as safety issue: No ]

To describe the overall survival in patients with ACLA-NSCLC [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Patients enrolled in this study will have standard treatment as per the discretion of their attending physician. The only additional requirement is that they would be asked is to complete questionnaires

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Patients with Centrally Located Advanced NSCLC who are Asymptomatic and who are not Suitable for Curative Treatment

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC

Central disease, as defined by tumour (either primary or nodal disease) arising or extending within a 2cm circumferential expansion from the centre of the trachea or within the zone of the proximal bronchial tree

Disease is visible on thoracic CT (diagnostic or simulation)

Asymptomatic from intra-thoracic tumour (may have background chest symptoms related to underlying COAD etc, but these symptoms must not have worsened due to tumour)

Patient (due to age or co-morbidities) or tumour (due to locally advanced or metastatic disease) is not suitable for radical treatment (defined as surgery or RT dose >50Gy in 20 fractions or equivalent).

Previous chemotherapy, thoracic RT or surgery is allowed

RT to other metastases (e.g. brain, bone etc) is allowed

•≥ 18 years of age

Able to provide written informed consent

Exclusion Criteria:

Intra-thoracic disease is peripheral only, not extending within 2cm of trachea/proximal bronchial tree

Symptomatic from intra-thoracic NSCLC

Histological diagnosis of small cell lung cancer, or malignant mediastinal lymphadenopathy from another malignancy (not NSCLC)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279408